PMDA-2022-0043
This application view consolidates identifiers, linked product and market authorization context, dossier structure, sequence history, and active authority obligations in one place. Regulatory teams use it to understand readiness and risk before publishing new sequences or responding to open questions. Cross-links to labeling and variations maintain lifecycle traceability for post-approval changes. Inspection readiness risk is calculated from overdue commitments, failed sequences, and unresolved high-risk correspondence for immediate action.
Application ID
APP-043
Application Number
PMDA-2022-0043
Procedure Type
Label Update
Status
Pending
Linked Product
Market Authorization
Spain · PMDA
Dossier Structure View
| Dossier | Format | Version | Modules | Module Breakdown | Status |
|---|---|---|---|---|---|
| DOS-043 | eCTD | 8.8.0 | 5 | M1 (9), M2 (4), M3 (15), M4 (3), M5 (6) | Failed |
Sequence Timeline
Open Questions and Commitments
| Question | Due Date | Risk | Status |
|---|---|---|---|
| Information request: manufacturing process change justification | 2025-03-12 | low | In Progress |
| Request for updated SmPC section 4.1 | 2024-12-23 | low | Draft |
| GMP inspection findings clarification | 2025-01-13 | low | Overdue |
| Query: container closure integrity study methodology | 2025-04-08 | medium | Overdue |
| Commitment | Due Date | Priority | Status |
|---|---|---|---|
| Submit final study report for paediatric use study KCL-PED-001 | 2024-12-14 | low | Overdue |
| Submit final study report for paediatric use study KCL-PED-001 | 2025-03-18 | low | In Progress |
| Submit annual PSUR covering the period Jan 2024 – Dec 2024 | 2025-12-08 | medium | Open |
Linked Labeling and Variations
| Labeling Artifact | Type | Version | Status |
|---|---|---|---|
| LBL-127 | PIL | 1.3 | Submitted |
| LBL-128 | IFU | 13.0 | Approved |
| LBL-129 | PIL | 19.9 | Approved |
| Variation | Type | Status | Submitted |
|---|---|---|---|
| PMDA-2022-0043-V043 | Minor | In Progress | 2023-04-17 |
| PMDA-2022-0043-V143 | Type IA | In Progress | pending |
| PMDA-2022-0043-V243 | Minor | Overdue | 2024-03-07 |
| PMDA-2022-0043-V343 | Type IA | In Progress | pending |
| PMDA-2022-0043-V443 | Type II | Approved | pending |
Inspection Readiness Risk Panel
Risk Score: 4 · Overdue commitments: 1, failed/blocked sequences: 1, high-risk questions: 0.
Recommended next step: resolve outstanding questions and commitments before next publishing cycle to reduce inspection exposure.